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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Sigma Tau to the U.S. FDA. Original Data : FDA Website

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01 117 ALPHA-ESTRADIOL

02 12,2'-(ETHYLENEDIIMINO) DIBUTYRIC ACID

03 12-DEOXY-D-GLUCOSE

04 12-DEOXYCYTIDINE

05 15-BROMO-2'-DEOXYURIDINE

06 16-AMINONICOTINAMIDE

07 16-MERCAPTOPURINE HYDRATE AS OBTAINED FROM PHARMA-WALDHOF GmbH

08 1A-KETOISOCAPROIC ACID, SODIUM SALT

09 1ACETOHYDROXAMIC ACID

10 1ACETYL-BETA-METHYLCHOLINE CHLORIDE

11 1ACETYLCHOLINE CHLORIDE

12 1ADENINE - PRODUCT NO. 8626 FD

13 1ADENOSINE 5' TRIPHOSPHATE (ATP) DISODIUM SALT

14 1ADENOSINE, SIGMA GRADE

15 1ADENYLOSUCCINIC ACID

16 1ALPHA-LINOLENIC ACID

17 1AMETHOPTERIN (METHOTREXATE)

18 1AMINO ACIDS & THEIR SODIUM SALT DERIVATIVES RELATIVE TO HFN-130 INDs

19 1AMINO ACIDS: L-ARGININE, FREE BASE AND L-ARGININE, HYDROCHLORIDE

20 1AMINOOXY ACETIC ACID

21 1ANGIOTENSIN I

22 1ANTHRAX ANIMAL MODEL LOCATED IN BETHESDA, MARYLAND

23 1ANTI-FUNGAL DRUGS

24 1ANTIPYRINE AS PRODUCED IN THE ST. LOUIS, MISSOURI PLANT

25 1APOMORPHINE HCl

26 1APROTININ, BOVINE LUNG

27 1ARECOLINE HYDROBROMIDE

28 1ATROPINE METHYL NITRATE AS SUPPLIED BY MAC FARALAN SMITH, LIMITED

29 1B-MERCAPTOCTHYLAMINE HYDROCHLORIDE (CYSTEAMINE)

30 1B-NICOTINAMIDE ADENINE DINUCLEOTIDE

31 1BACITRACIN ZINC

32 1BETA-AMINOPROPIONITRILE MONOFUMARARTE SALT

33 1BETA-ESTRADIOL

34 1BETA-ESTRADIOL-3-BENZOATE

35 1BETA-GLYCEROPHOSPHATE GRADE XII CALCIUM SALT

36 1BETA-PHENYLETHYLAMINE HYDROCHLORIDE

37 1BETAINE FREE BASE ANHYDROUS PURCHASED BY SIGMA LTD LONDON FOR USA

38 1BIOACTIVE PEPTIDES (FORMERLY SOMATOSTATIN)

39 1BRADYKININ ACETATE SALT

40 1CATABATE, SODIUM OXYBATE, GAMMA-HYDROXYBUTYRIC ACID, SODIUM SALT

41 1CATALASE

42 1CHOLESTEROL

43 1CHOLIC ACID SODIUM SALT

44 1CHOLINE CHLORIDE

45 1COLLAGEN (PRODUCT NO. C 9301)

46 1CORTICOSTERONE

47 1COUMARIN

48 1CYCLOHEXIMIDE

49 1D (+) GALACTOSE PRODUCT NO. G 0750 FD

50 1D (-) PENICILLAMINE

51 1D (-)-RIBOSE PRODUCT # R 7500 FD

52 1D-AMPHETAMINE SULFATE # A5880 FD & (+) METHAMPHETAMINE HCL NO. M8750FD

53 1D-ARGININE HYDROCHLORIDE

54 1D-GLUCONIC ACID HEMI CALCIUM SALT

55 1D-PANTETHINE

56 1D-PHENYLALANINE

57 1DEHYDROISOANDROSTERONE-3-SULFATE,SODIUM SALT

58 1DEHYROISOANDROSTERONE

59 1DELTA-AMINOLEVULINIC ACID HCL

60 1DEOXYCHOLIC ACID,SODIUM SALT

61 1DEOXYRIBONUCLEASE I (PROD. NO. D 5025)

62 1DEUTERIUM OXIDE

63 1DEXTROMETHORPHAN HYDROBROMIDE

64 1DIAMINE OXIDASE

65 1DIETHYLENETRIAMINE PENTACETIC ACID TRISODIUM ZINC SALT, 0.5 MOLAR SOL.

66 1DIETHYLENETRIAMINEPENTAACETIC ACID (CLINICAL STUDY BY D.HONEYCHURCH)

67 1DIMETHYL SULFOXIDE

68 1DIPYRIDAMOLE: SPECIFICATIONS AND RELABELLING

69 1DL-3,4- DIHYDROXYPHENYLGLYCOL #D9753FD

70 1DL-5-FLUOROTRYPTOPHAN

71 1DL-6,8-THIOTIC ACID, OXIDIZED FORM CLINICAL STUDIES BY DR. R. JACOBSON

72 1DL-6-METHYL-5,6,7,8-TETRAHYDROPTERINE

73 1DL-BETA-HYDROXYBUTYRIC ACID, SODIUM SALT

74 1DL-CARNITINE

75 1DL-PHENYLALANINE

76 1DL-THERO-3,4-DIHYDROXYPHENYLSERINE

77 1ESERINE SALICYLATE SALT

78 1ETHANOL SOLUTION OF CARDIOLIPIN SODIUM SALT (SIGMA CHEMICAL COMPANY)

79 1ETIOCHOLAAN-3 ALPHA-OL-17-ONE

80 1FRUCTOSE 1,6-DIPHOSPHATE

81 1FUSARIC ACID

82 1GLUCOSIDASE

83 1GLUTATHIONE OXIDIZED

84 1GLUTATHIONE, FREE ACID REDUCED FORM

85 1GLYCINE

86 1HEPES, FREE ACID AND HEPES, SODIUM SALT

87 1HEPES, SODIUM SALT (N-2-HYDROXYETHYLPIPERAZINE-N'-2-ETHANESULFONIC ACID)

88 1HISTOPAQUE (1077 & 1119) & PHYSIOLOGICAL SALTS MIXTURES PROC ST. LOUIS

89 1HYALURONIDASE.

90 1HYDRAZINE SULFATE (FAIRMOUNT CHEMICAL)

91 1INDOMETHACIN

92 1INOSINE

93 1INSULIN FROM BOVINE PANCREAS

94 1ISONICOTINIC ACID HYDRAZIDE

95 1L-ALANINE

96 1L-ALPHA-PHOSPHATIDYL CHOLINE TYPE II-S

97 1L-ALPHA-PHOSPHATIDYLCHOLINE TYPE XIII-E MDG. IN MISSOURI

98 1L-AMINO-n-BUTYRIC ACID

99 1L-ARGININE HYDROCHLORIDE

100 1L-ASPARTIC ACID

101 1L-B-3,4-DIHYDROXYPHENYLALANINE (L-DOPA) AND METHYL ESTER HCL.

102 1L-CARNITINE HCl (FIRST RUN)

103 1L-CYSTEINE

104 1L-GLUTAMIC ACID

105 1L-ISOLEUCINE

106 1L-LEUCINE

107 1L-LYSINE MONO HCl

108 1L-ORNITHINE HCL

109 1L-PHENYLALANINE

110 1L-PROLINE

111 1L-SERINE - (S 4500 FD

112 1L-THREONINE

113 1L-TRYPTOPHAN

114 1L-TYROSINE

115 1L-VALINE

116 1MELATONIN

117 1MESO-2,3-DIMERCAPTOSUCCINIC ACID

118 1METHIONINE ENKEPHALIN-ACETATE SALT

119 1METHYL COBALAMINE

120 1METHYLENE DIPHOSPHORIC ACID

121 1MUSCIMOL

122 1MYO-INOSITOL

123 1N,N-DIMETHYLTRYPTAMINE

124 1N-(2-MERCAPTOPROPIONYL) GLYCINE

125 1N-DODECYL B-D-MALTOSIDE, PRODUCT NO. D 4641 IN ST.LOUIS, MO.

126 1N-HYDROXYSUCCINIMIDOBIOTIN - PRODUCT NO. H 1759 FD

127 1NALOXONE HCL.AS RELABELLED FOR SIGMA

128 1NICOTINE #3876 FD

129 1O-PHTHALDIALDEHYDE

130 1OLEIC ACID SODIUM 95%

131 1OROTIC ACID

132 1OROTIC ACID ANHYDROUS

133 1PHENOLPHTHALEIN GLUCURONIC ACID

134 1PHENYLACETIC ACID

135 1POLY (ALA,GLU,LYS-HBR,TYR) 6:2:5:1

136 1POLYETHYLENE GLYCOL

137 1PROGESTERONE

138 1PYRIDOXAL 5-PHOSPHATE

139 1PYRIDOXAL HYDROCHLORIDE

140 1PYRUVIC ACID SODIUM SALT

141 1QUINACRINE HCL.

142 1SELENO-DL-METHIONINE AS SUPPLIED BY SIGMA (ISRAEL)CHEMICAL COMPANY

143 1SODIUM PARA-AMINOBENZOATE

144 1SOMATOSTATIN (PRODUCT NO. S 9129 FD)

145 1STEARYLAMINE AS PROCESSED BY ARMAK FOR SIGMA F & D

146 1STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN ROCKAWAY, NJ

147 1STERILE PROCESSING DETAILS OF PHASE - 18

148 1SUCCINIC ACID,DISODIUM HEXAHYDRATE

149 1TAURINE

150 1TES(N-tris[ HYRDOXYMETHYL ] methy 2-aminoethanesulfonic acid)

151 1TESTOSTERONE

152 1TETRAETHYLAMMONIUM CHLORIDE

153 1THIOPROLINE

154 1THYMIDINE

155 1TOXICITY REPORTS FOR KOLLICOATS RS 30 D PROCESSS FACILITY

156 1TRIMETHOPRIM

157 1TRIOLEIN

158 1TRIZMA BASE AS PROCESSED IN THE SAINT LOUIS, MISSOURI FACILITIES

159 1TRIZMA HYDROCHLORIDE

160 1TRYPSIN INHIBITOR,-T AND ALPHA-CHYMOTRYPS

161 1TRYPSIN TYPE III, BOVINE

162 1TYRAMINE HYDROCHLORIDE

163 1URIDINE

164 1YOHIMBINE HYDROCHLORIDE

165 1d-BIOTIN

166 1l ETHYL-3-(3-DIMETHYLAMINOPROPYL) CARBODIIMIDE HCl ST. LOUIS,MO PLANT

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